US-based
genetic testing company 23andMe has launched its controversial 'personal genome service' in the UK.

The launch comes after the
UK regulator, the Medicines and Healthcare Regulatory Agency (MHRA), approved the test kit after testing to ensure certain minimum safety standards were met. The MHRA did not test the reliability of the genome testing service as this is beyond their remit.

Sold at a cost of £125 per person, the service uses information obtained from DNA analysis of a saliva sample to estimate a person's genetic risk for ovarian and
breast cancer, Alzheimer's disease, and other traits like baldness. It also claims
to provide information on ancestry, with the company saying that customers could
'discover and communicate with new relatives as
part of 23andMe's DNA Relatives feature'.

Anne Wojcicki, CEO and co-founder of
23andMe, told The Telegraph the company aims to 'fundamentally change the healthcare system' by putting health risk information directly in people's hands. In a statement, she added that 23andMe's
service would 'ensure individuals can personally access, understand and benefit
from the human genome'.

A UK Department of Health (DH) spokesperson told The Telegraph that 'initiatives that help to raise awareness of genomics and those which enable people to take more interest in their personal health' were welcome. The spokesperson nonetheless urged people 'to think carefully before using private genomic services as no test is 100 percent reliable'.

In 2013, the US Food and Drug Administration banned the company from marketing some of its
health-related services for failing to provide evidence on the reliability of
its results (see BioNews 733). Of particular concern were tests that analysed customers' DNA for
gene variants linked to life-threatening diseases and drug responses.

At
the time, the FDA noted that the company's services could mislead customers
into making life-changing health decisions based on imprecise results. For
example, low risk results could give false reassurance to customers, preventing
them from seeking treatment on time.

BBC News reported the DH's assertion that 23andMe's UK offering would be
different from that banned in the USA. According to the spokesperson, 'many of the drug responses, inherited conditions and genetic
health risks that were of concern in the US have been removed'.

A
statement from the company, however, notes that while the tailored health
report is not intended to be diagnostic, it includes 'results for genes
associated with certain inherited conditions such as cystic fibrosis or sickle cell anaemia'.

The
service will also test 'for genes that may reveal risk factors for certain
diseases or conditions such as blood clotting, Alzheimer's disease or Parkinson's
disease, and how your body may respond to specific medications, such as warfarin or Hepatitis C treatments'.

The Alzheimer's Society issued a sceptical statement, advising: 'If you are worried about your memory,
your GP should be the first port of call - not a home DNA testing kit.'

The Society added that while 'research has identified a number
of genes that may play a role in the development of dementia' available
evidence was not conclusive enough to 'use such data as a diagnostic tool'.

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